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Cocaine Dependence clinical trials

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NCT ID: NCT06189690 Recruiting - Cocaine Dependence Clinical Trials

Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder

Start date: January 6, 2022
Phase: N/A
Study type: Interventional

This study aims to explore the effect of 5-Hz rTMS over the left dorsolateral prefrontal cortex on the BDNF, craving and cognitive function. This study will be longitudinal, with a short-term double-blind placebo-controlled phase consisting of 20 rTMS sessions and a long-term phase, consisting of 2 weekly sessions for 12 weeks. Participants will be clinically assessed pre-treatment (T0), after 20-sessions phase (T1) and after 12-weeks phase (T2) by an interview about psychiatric symptoms. Also, blood will be obtained in the same T0, T1 and T2 to peripheral levels of BDNF determination. Cognitive state will be measured at the same time-points (T0, T1, T2) by paper-pencil and computerized neuropsychological assessment. Researchers will compare active rTMS versus placebo 5 Hz-rTMS on described variables. Additionally, a comparative group (without rTMS intervention) will be included to equivalently measure described variables during periods without cocaine consumption.

NCT ID: NCT06159387 Recruiting - Cocaine Dependence Clinical Trials

Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts

Start date: October 23, 2023
Phase: Phase 4
Study type: Interventional

2.1. General To evaluate the efficacy and safety of a Cannabis sativa extract (CBD (Cannabidiol) + up to 0.3% THC (Delta-9-tetrahydrocannabinol)), compared to placebo, in the treatment of cocaine/crack use disorder. 2.2. Specifics - Compare the amount and frequency of cocaine use between the group treated with Cannabis sativa extract and the placebo group - Compare adherence to treatment between the group treated with Cannabis sativa extract and the placebo group - Evaluate the prevalence and intensity of depressive and anxious symptoms in patients using Cannabis sativa extract compared to patients using placebo - Evaluate the incidence and severity of side effects in the active group compared to placebo.

NCT ID: NCT06125054 Recruiting - Cocaine Dependence Clinical Trials

Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction

Co-Boost
Start date: February 5, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the effects of the combination of ketamine and realtime functional magnetic resonance imaging (fMRI) neurofeedback training in individuals with cocaine use disorder. The main questions the investigators aim to answer are: - Can the investigators observe a positive, significant effect on percentage of cocaine use days of both interventions combined as well as stand alone interventions? - Is there a significant transfer effect of the neurofeedback training? - Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens? Participants will be given ketamine and a realtime fMRI neurofeedback training. Both interventions are placebo-controlled. The investigators will compare the four intervention groups to investigate the effects of the stand-alone effects of the intervention and the combination of it.

NCT ID: NCT05857852 Recruiting - Cocaine Dependence Clinical Trials

Low-Intensity Focused Ultrasound for Cocaine Use Disorder

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This study aims to understand the role of Low-Intensity Focused Ultrasound on craving levels for cocaine as evidenced by diagnostic imaging of the dorsal anterior insula (dAI) and subjective ratings. Data analysis will serve to show if 1) LIFU is safe and effective and to 2) examine the effects of LIFU on dAI BOLD activity and craving in response to cocaine cue-exposure. The study will screen 60 individuals with Cocaine Use Disorder (CUD) to arrive at 30 enrolled subjects, based on a 2:1 screen/randomization ratio.

NCT ID: NCT05562349 Recruiting - Cocaine Dependence Clinical Trials

Clavulanic Acid for the Treatment of Cocaine Use Disorder

Start date: May 3, 2023
Phase: Phase 2
Study type: Interventional

A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)

NCT ID: NCT04994821 Recruiting - Cocaine Dependence Clinical Trials

tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study

Start date: September 28, 2020
Phase: Phase 2
Study type: Interventional

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.

NCT ID: NCT03833583 Recruiting - Cocaine Dependence Clinical Trials

tDCS to Reduce Craving in Cocaine Addiction

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In the present study, tDCS will be administered with the goal of assessing the tolerability and feasibility of this approach to 1) reduce an individual's level of drug craving and 2) provide evidence to support the use of this device by the patient for future unsupervised stimulation in a non-clinical setting. Research Questions: - Can tDCS be used successfully to train cocaine addicted individuals for self-administration purposes? - Can active tDCS be used to decrease drug craving in individuals with cocaine use disorders? - Does active tDCS outperform sham tDCS in reducing drug craving?

NCT ID: NCT03333460 Recruiting - Clinical trials for Substance Use Disorders

Transcranial Magnetic Stimulation for Cocaine Addiction

BRAINSWITCH
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Background: Cocaine use disorders (CUD) is a complex brain disorder, involving several brain areas and neurocircuits. Effective treatments for CUD are still needed. Repetitive transcranial magnetic stimulation (rTMS) stimulates non-invasively parts of the brain. Preliminary data suggest that rTMS may help reducing cocaine craving and consumption. Researchers want to learn how the brain and the drug-seeking behavior may change with this treatment. Objectives: To test if rTMS can reduce cocaine craving and use, and also affect several mood, behavioral and cognitive alterations associated with prolonged cocaine use. Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study. The study includes three phases: 1) a rTMS continued treatment phase; a rTMS follow-up; and a no rTMS follow-up. Prior to participating, participants will be screened with: - Questionnaires - Medical history - Physical exam - Urine tests - MRI (structural) After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will undergo: - Questionnaires - Functional MRI During the continued rTMS phase, participants with cocaine use disorder will be randomized to receive real or fake rTMS. Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly), during which they will receive rTMS, and behavioral and imaging assessments will be performed. At the end of the rTMS follow up period, participants will further receive 3 follow up visits (once a month), during which rTMS will not be performed, but behavioral data will be collected. Treatment includes: - rTMS: A coil is placed on the head. A brief electrical current passes through the coil. At each visit, participants will receive two rTMS sessions, with a 1hr interval between sessions. At the beginning of each rTMS session, they view cocaine-related images for few minutes. - MRIs at baseline and at follow-up visit #12: Participants lie on a table that slides into a cylinder that takes pictures of the brain. They respond to images while in the scanner. - Repeat of screening tests and questionnaires - Urine toxicological screen

NCT ID: NCT02927236 Recruiting - Cocaine Dependence Clinical Trials

Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use

Start date: February 13, 2017
Phase: Phase 4
Study type: Interventional

Background: More effective treatments for people with cocaine use disorder are needed. Researchers want to understand the parts of the brain involved in the disorder. Transcranial magnetic stimulation (TMS) stimulates parts of the brain. A form of TMS called intermittent theta-burst stimulation (iTBS) may help reduce cocaine use. Researchers want to learn how the brain might change with treatment. Objectives: To test if iTBS can reduce cocaine use. Also, to learn how cocaine changes the heart and the brain. Eligibility: Healthy, right-handed adults ages 18-60 who do or do not have cocaine use disorder. Design: Participants will be screened with: - Questionnaires - Medical history - Physical exam - Blood and urine tests - Alcohol breath tests In the pilot study, 10 participants with cocaine use disorder will have 10 treatment days over 2 weeks. Half will be inpatient and half will be outpatient. They will have 2 follow-up visits. Treatment includes: - iTBS: A coil is placed on the head. A brief electrical current passes through the coil. They view cocaine-related images during each session. Sessions are videotaped. - Repeat of screening tests - In the main study, participants will be randomly assigned to have either real or fake iTBS. - Participants with cocaine use disorder will join an incentive program to quit. - Participants will have 39 visits over 6 months. These include: - Repeat of screening tests - MRIs at 5 visits: Participants lie on a table that slides into a cylinder that takes pictures of the brain. They respond to images while in the scanner. - iTBS at 10 visits (5 days a week for 2 weeks) Participants will be contacted throughout the study to discuss iTBS treatment and drug use.

NCT ID: NCT02455479 Recruiting - Cocaine Dependence Clinical Trials

Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals

Start date: June 26, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of a vaccine to treat the neurological effects of cocaine by evoking "immunity" to prevent the effects of cocaine on the brain.